Standard Hypercaloric, Hyperproteic vs. Leucine-Enriched Oral Supplements in Patients with Cancer-Induced Sarcopenia, a Randomized Clinical Trial.

(1) Background: Malnutrition frequently affects patients with cancer, and it negatively impacts treatment tolerance, clinical outcomes and survival. Thus, appropriate nutritional screening and early nutrition support are extremely recommended. Currently, a significant number of oral supplements (OS) are commercially available; despite this, there is a lack of evidence for recommending specific OS, including leucine-enriched OS, for nutritional support in patients with cancer. (2) Aim: To compare the clinical evolution of patients with cancer (undergoing systemic treatment) that received standard hypercaloric, whey protein-based hyperproteic oral supplements vs. hypercaloric, hyperproteic leucine-enriched OS using a novel morphofunctional nutritional evaluation. (3) Patients and methods: This paper details an open-label, controlled clinical study in which patients were randomly assigned to receive nutritional treatment with whey protein-based hyperproteic oral supplements (control group) vs. hypercaloric, hyperproteic leucine-enriched OS (intervention group) during a twelve-week period. Forty-six patients were included; epidemiological, clinical, anthropometric, ultrasound (muscle echography of the rectus femoris muscle of the quadriceps and abdominal adipose tissue) and biochemical evaluation were performed. All patients received additional supplementation with vitamin D. (4) Results: Nutritional parameters (including bioimpedance, anthropometric, ultrasound and biochemical variables) of all included patients remained stable after the nutritional intervention. Extracellular mass tended to increase in the patients that received the leucine-enriched formula. Functionality (evaluated through the stand-up test) improved in both groups (p < 0.001). Prealbumin, transferrin levels and superficial adipose tissue increased in the control group (p < 0.05), while self-reported quality of life improved in all the evaluated patients (p < 0.001). (5) Conclusions: Nutritional support with hypercaloric, hyperproteic (with whey protein) OS and vitamin D supplementation were associated with the maintenance of body composition and improvements in functionality and in quality of life in the patients with cancer undergoing systemic treatment. No significant benefits were observed when a leucine-enriched formula was used.

Mediterranean Diet, Vitamin D, and Hypercaloric, Hyperproteic Oral Supplements for Treating Sarcopenia in Patients with Heart Failure-A Randomized Clinical Trial.

BACKGROUND: Malnutrition and sarcopenia frequently affect patients with heart failure (HF), in which clinical outcomes and survival is decreased. Thus, appropriate nutritional screening and early nutrition support are highly recommended. Currently, nutritional support is not a standard of care in patients with HF, and the use of commercially available oral supplements (OSs) could provide an additional benefit to medical treatment in these patients. AIM: To compare the effect of the Mediterranean diet in combination with hypercaloric, hyperproteic OS in patients with HF. PATIENTS AND METHODS: An open label, controlled clinical study in which patients were randomly assigned to receive a Mediterranean diet (control group) vs. hypercaloric, hyperproteic OS (intervention group) for twenty-four weeks. Thirty-eight patients were included; epidemiological, clinical, anthropometric, ultrasound (muscle echography of the rectus femoris muscle of the quadriceps and abdominal adipose tissue), and biochemical evaluations were performed. All patients received additional supplementation with vitamin D. RESULTS: Baseline malnutrition according to the GLIM criteria was observed in 30% of patients, while 65.8% presented with sarcopenia. Body cell mass, lean mass, and body mass increased in the intervention group (absolute increase of 0.5, p = 0.03, 1.2 kg, p = 0.03, and 0.1 kg, p = 0.03 respectively). In contrast, fat mass increased in the control group (4.5 kg, p = 0.05). According to the RF ultrasound, adipose tissue, muscle area, and circumference tended to decrease in the intervention group; it is probable that 24 weeks was too short a period of time for evaluating changes in muscle area or circumference, as previously observed in another group of patients. In contrast, functionality, determined by the up-and-go test, significantly improved in all patients (difference 12.6 s, p < 0.001), including the control (10 s improvement, p < 0.001) and the intervention group (improvement of 8.9 s, p < 0.001). Self-reported QoL significantly increased in all groups, from 68.7 ± 22.2 at baseline to 77.7 ± 18.7 (p = 0.01). When heart functionality was evaluated, LVEF increased in the whole cohort (38.7 ± 16.6 vs. 42.2 ± 8.9, p < 0.01); this increase was higher in the intervention group (34.2 ± 16.1 at baseline vs. 45.0% ± 17.0 after 24 weeks, p < 0.05). Serum values of NT-proBNP also significantly decreased in the whole cohort (p < 0.01), especially in the intervention group (p = 0.02). After adjusting by age and sex, nutritional support, baseline LVEF, NT-proBNP, and body composition parameters of functionality tests were not associated with mortality or new hospital admissions in this cohort. CONCLUSION: Nutritional support with hypercaloric, hyperproteic OS, Mediterranean diet, and vitamin D supplementation were associated with decreased NT-proBNP and improvements in LVEF, functionality, and quality of life in patients with HF, despite a significant decrease in hospital admissions.

Morphofunctional and Molecular Assessment of Nutritional Status in Head and Neck Cancer Patients Undergoing Systemic Treatment: Role of Inflammasome in Clinical Nutrition.

Malnutrition in patients with head and neck cancer is frequent, multifactorial and widely associated with clinical evolution and prognosis. Accurate nutritional assessments allow for early identification of patients at risk of malnutrition in order to start nutritional support and prevent sarcopenia. We aimed to perform a novel morphofunctional nutritional evaluation and explore changes in inflammasome-machinery components in 45 patients with head and neck cancer who are undergoing systemic treatment. To this aim, an epidemiological/clinical/anthropometric/biochemical evaluation was performed. Serum RCP, IL6 and molecular expression of inflammasome-components and inflammatory-associated factors (NOD-like-receptors, inflammasome-activation-components, cytokines and inflammation/apoptosis-related components, cell-cycle and DNA-damage regulators) were evaluated in peripheral-blood mononuclear-cells (PBMCs). Clinical-molecular correlations/associations were analyzed. Coherent and complementary information was obtained in the morphofunctional nutritional assessment of the patients when bioimpedance, anthropometric and ultrasound data were analyzed. These factors were also correlated with different biochemical and molecular parameters, revealing the complementary aspect of the whole evaluation. Serum reactive C protein (RCP) and IL6 were the most reliable parameters for determining patients with decreased standardized phase angle, which is associated with increased mortality in patients with solid malignancies. Several inflammasome-components were dysregulated in patients with malnutrition, decreased phase angle and dependency grade or increased circulating inflammation markers. A molecular fingerprint based on gene-expression of certain inflammasome factors (p27/CCL2/ASC) in PBMCs accurately differentiated patients with and without malnutrition. In conclusion, malnutrition induces a profound alteration in the gene-expression pattern of inflammasome-machinery components in PBMCs. A comprehensive nutritional assessment including novel morphofunctional techniques and molecular markers allows a broad characterization of the nutritional status in cancer patients. Profile of certain inflammasome-components should be further studied as potential targets for nutrition-focused treatment strategies in cancer patients.

[Nutritional approach in systemic sclerosis: report of a case]. / Abordaje nutricional en esclerodermia: a propósito de un caso.

INTRODUCTION: Background: systemic sclerosis is a rare systemic acquired disease with a complex pathogenesis which compromises multiple organs. The nutritional approach to treat patients with this disease is not clearly stablished due to its low prevalence. Case report: we present the case of a 37-year-old woman diagnosed with systemic sclerosis with gastrointestinal compromise, 40% weight loss since diagnosis and severe anemia. Despite oral supplementation, placement of a gastrostomy feeding tube and medical therapy with octreotide, her nutritional requirements are not achieved, so we suggest home parenteral nutrition to complete the nutritional support. Discussion: the severe intestinal affection in this patient made it necessary to turn to the parenteral access because of the oral intolerance secondary to the intestinal pseudo-obstruction. In these cases, the lack of etiological treatment makes home parenteral nutrition play an important role in the nutritional approach.

INTRODUCCIÓN: Introducción: la esclerodermia es una enfermedad sistémica adquirida poco frecuente, con una patogenia compleja que compromete a numerosos órganos. El abordaje nutricional no está claramente establecido debido a su baja prevalencia. Caso clínico: presentamos el caso de una mujer de 37 años diagnosticada de esclerodermia difusa con amplia afectación gastrointestinal, pérdida de 40% de peso desde el diagnóstico y anemia grave. A pesar de la toma de suplementos orales, la nutrición a través de gastrostomía y el uso de octreótide, no se alcanzan los requerimientos nutricionales, por lo que se plantea el uso de nutrición parenteral domiciliaria junto al resto de tratamientos. Discusión: esta paciente, la progresión de la afectación digestiva debida a la esclerodermia hizo necesario recurrir al aporte parenteral debido a la intolerancia oral a causa de la pseudooclusión intestinal. En estos casos, la ausencia de tratamiento etiológico hace que la nutrición parenteral domiciliaria juegue un papel importante en el soporte nutricional.

Abordaje nutricional en esclerodermia: a propósito de un caso / Nutritional approach in systemic sclerosis: report of a case

Introducción: la esclerodermia es una enfermedad sistémica adquirida poco frecuente, con una patogenia compleja que compromete a numerosos órganos. El abordaje nutricional no está claramente establecido debido a su baja prevalencia. Caso clínico: presentamos el caso de una mujer de 37 años diagnosticada de esclerodermia difusa con amplia afectación gastrointestinal, pérdida de 40% de peso desde el diagnóstico y anemia grave. A pesar de la toma de suplementos orales, la nutrición a través de gastrostomía y el uso de octreótide, no se alcanzan los requerimientos nutricionales, por lo que se plantea el uso de nutrición parenteral domiciliaria junto al resto de tratamientos. Discusión: esta paciente, la progresión de la afectación digestiva debida a la esclerodermia hizo necesario recurrir al aporte parenteral debido a la intolerancia oral a causa de la pseudooclusión intestinal. En estos casos, la ausencia de tratamiento etiológico hace que la nutrición parenteral domiciliaria juegue un papel importante en el soporte nutricional

Background: systemic sclerosis is a rare systemic acquired disease with a complex pathogenesis which compromises multiple organs. The nutritional approach to treat patients with this disease is not clearly stablished due to its low prevalence. Case report: we present the case of a 37-year-old woman diagnosed with systemic sclerosis with gastrointestinal compromise, 40% weight loss since diagnosis and severe anemia. Despite oral supplementation, placement of a gastrostomy feeding tube and medical therapy with octreotide, her nutritional requirements are not achieved, so we suggest home parenteral nutrition to complete the nutritional support. Discussion: the severe intestinal affection in this patient made it necessary to turn to the parenteral access because of the oral intolerance secondary to the intestinal pseudo-obstruction. In these cases, the lack of etiological treatment makes home parenteral nutrition play an important role in the nutritional approach

Early nutrition support therapy in patients with head-neck cancer.

BACKGROUND: weight loss is commonly observed in head-neck cancer patients, affecting 75-80% of them during their treatment period; weight loss is severe in 30-50% of cases. According to ESPEN publications, nutritional assessment in cancer patients should be frequently performed and nutrition support therapy must be started when any deficiency is observed. OBJECTIVE: to evaluate the effect of early nutrition support (ENS) in nutritional markers and treatment response in patients with head-neck cancer receiving radiotherapy (RT). PATIENTS AND METHODS: one hundred and two patients with head-neck cancer and more than two points in the malnutrition screening tool (MUST) before receiving RT were included. ENS was provided to all patients consisting in nutrition counselling, oral supplements and/or enteral nutrition. RESULTS: one hundred and two patients were included; 76% had a stage IV of disease. At the end of RT, after ENS, a slightly decreased body mass index (BMI) with an increased fat-free body mass was observed (p < 0.001); biochemical nutrition parameters remained stable despite decreased oral intake. Less than 40% of patients had severe epithelitis or mucositis; 92% of patients received the total amount and doses of originally planned RT sessions, while 22.8% required RT-sessions interruption. Patients with caloric malnutrition had a lower fulfillment of RT than those without caloric malnutrition (p < 0.001). Mortality was related to lower Karnosfsky, higher weight loss before RT and higher grade of mucositis/epitelitis (p < 0.05). CONCLUSIONS: patients who receive ENS keep their nutritional condition instead of associated effects due to RT. ENS represents an efficient treatment and could prevent malnutrition associated comorbidities in oncologic patients.

Early nutrition support therapy in patients with head-neck cancer / Soporte nutricional precoz en pacientes con cáncer de cabeza y cuello

Background: weight loss is commonly observed in head-neck cancer patients, affecting 75-80% of them during their treatment period; weight loss is severe in 30-50% of cases. According to ESPEN publications, nutritional assessment in cancer patients should be frequently performed and nutrition support therapy must be started when any deficiency is observed. Objective: to evaluate the effect of early nutrition support (ENS) in nutritional markers and treatment response in patients with head-neck cancer receiving radiotherapy (RT).Patients and methods: one hundred and two patients with head-neck cancer and more than two points in the malnutrition screening tool (MUST) before receiving RT were included. ENS was provided to all patients consisting in nutrition counselling, oral supplements and/or enteral nutrition. Results: one hundred and two patients were included; 76% had a stage IV of disease. At the end of RT, after ENS, a slightly decreased body mass index (BMI) with an increased fat-free body mass was observed (p < 0.001); biochemical nutrition parameters remained stable despite decreased oral intake. Less than 40% of patients had severe epithelitis or mucositis; 92% of patients received the total amount and doses of originally planned RT sessions, while 22.8% required RT-sessions interruption. Patients with caloric malnutrition had a lower fulfillment of RT than those without caloric malnutrition (p < 0.001). Mortality was related to lower Karnosfsky, higher weight loss before RT and higher grade of mucositis/epitelitis (p < 0.05).Conclusions: patients who receive ENS keep their nutritional condition instead of associated effects due to RT. ENS represents an efficient treatment and could prevent malnutrition associated comorbidities in oncologic patients

Antecedentes: la pérdida de peso es un síntoma frecuente en el cáncer de cabeza y cuello (CCC), afecta a un 75-80% de los pacientes y es severa en un 30-50% de los casos. Según las publicaciones de la ESPEN, la valoración nutricional puede realizarse periódicamente y se debe comenzar el soporte nutricional cuando se observe algún déficit nutricional. Objetivo: evaluar el efecto del soporte nutricional precoz (SNP) en marcadores nutricionales y la respuesta terapéutica en pacientes con CCC que reciben radioterapia (RT). Pacientes y métodos: se incluyeron 102 pacientes con CCC que tuviesen al menos dos puntos en la escala de screening nutricional (MUST) antes de recibir RT. Todos los pacientes recibieron SNP, que consistió en asesoramiento nutricional y suplementos orales o nutrición enteral. Resultados: se incluyeron 102 pacientes, el 76% de ellos en estadio IV de la enfermedad. Al final de la RT, después de recibir SNP, se observó una disminución discreta en el índice de masa corporal (IMC) acompañada de aumento de la masa libre de grasa (p < 0,001); los parámetros bioquímicos nutricionales permanecieron estables a pesar de la disminución en la ingesta. La incidencia de mucositis o epitelitis severa fue menor al 40%; el 92% de los pacientes recibieron la totalidad de las sesiones de RT planeadas, mientras que solo el 22,8% interrumpió parcial o totalmente la RT. Aquellos pacientes con desnutrición calórica previa tuvieron un menor cumplimiento terapéutico (p < 0,001). La mortalidad se relacionó con el índice de Karnosfsky, con una mayor pérdida de peso previa a la RT y mayor grado de mucositis o epitelitis (p < 0,05). Conclusiones: aquellos pacientes que reciben SNP mantienen su estado nutricional a pesar de los efectos asociados con RT. El SNP representa una estrategia terapéutica eficiente para prevenir complicaciones relacionadas con la nutrición en pacientes oncológicos

Variations in diabetes remission rates after bariatric surgery in Spanish adults according to the use of different diagnostic criteria for diabetes.

BACKGROUND: There are multiple criteria to define remission of type 2 diabetes (DM2) after bariatric surgery but there is not a specific one widely accepted. Our objectives were to compare diagnostic criteria for DM2 remission after bariatric surgery: Criteria from Spanish scientific associations (SEEN/SEEDO/SED) and from the American Diabetes Association (ADA). We also aim to analyse the degree of correlation between these sets of criteria. METHODS: Retrospective observational study in 127 patients undergoing bariatric surgery in a single centre (Hospital Universitario Reina Sofía, Córdoba, Spain) between January 2001 and December 2009. We analysed DM2 remission following bariatric surgery comparing DM2 diagnostic criteria approved by Spanish scientific associations and ADA criteria. RESULTS: In total, 62.2% of patients were women; mean age was 47.1 years. Following surgery, 52% achieved complete remission according to ADA criteria, and 63.8% following the criteria approved by Spanish associations (p = 0.001);18.9 and 8.7%, respectively, showed partial remission (p = 0.007), and 29.1 and 27.6% no remission, according to the criteria approved by each association (p = 0.003). There was good correlation between both sets of criteria (Rho 0.781; p < 0.001). CONCLUSIONS: In our series, using more stringent criteria for defining DM2 remission (ADA criteria) results in a lower rate of remission, although we found a a high degree of correlation between both sets of criteria.

Uso de la glutamina en la nutricion parenteral total de pacientes sometidos a trasplante de médula ósea / Use of glutamine in total parenteral nutrition of bone marrow transplant patients

La glutamina es un amioácido esencial para la síntesis de nucleótidos y una fuente de energía para la replicación celular, existe evidencia contradictoria respecto a los beneficios de su administración como parte de la nutrición parenteral en pacientes sometidos a trasplante de médula ósea (TMO). Más del 75% de los pacientes sometidos a trasplante de precursores hematopoyéticos, presentan durante su evolución complicaciones que comprometen el tracto digestivo, principalmente mucositis, limitando la ingesta oral, de allí la necesidad del uso de nutrición parenteral total (NPT) en estos casos. Objetivo: Analizar la relación entre uso de glutamina en la NPT de TMO y la evolución de complicaciones agudas como mucositis, EICH e infecciones, así como la estancia hospitalaria y los días de nutrición parenteral total. Material y métodos: Estudio observacional retrospectivo. Se incluyeron la totalidad de TMO con NPT entre 2007 y 2013 en nuestro hospital. Se analizaron días de hospitalización, días de soporte nutricional, uso de glutamina y complicaciones agudas. Los resultados se analizaron con el programa SPSS 15.0. Resultados: Se incluyeron 73 pacientes trasplantados, se dividieron en dos grupos según el aporte de glutamina siendo ambos grupos comparables entre sí. La edad media fue de 36,96±12,89 años. El 47,9% de los pacientes estudiados recibió suplemento de glutamina en la NPT. Los pacientes que recibieron glutamina tuvieron una estancia media de 31,49±7,41 días con 14,11±5,87 días de NPT en comparación a los que no recibieron glutamina con 32,16±7,99 y 15,50±7,71 días respectivamente (p=0,71 y 0,39). La duración de la mucositis en los pacientes que recibieron glutamina fue de 12,23±5,66 días comparado con 15,50±7,71 días en los que no recibieron glutamina (p=0,042).Se observaron grados severos de EICH (II, III) en un 20,6% de los pacientes sin glutamina en comparación al 13,7% en los que la recibieron (p=0,636). Del total de los de los pacientes estudiados, el 13,7% sufrieron complicaciones infecciosas mientras recibían NPT con glutamina, comparado con 16,4% en pacientes que no recibieron (p=0,700). Conclusiones: En nuestra serie, se observó una reducción estadísticamente significativa en la duración de la mucositis en pacientes que recibieron NPT con glutamina

Glutamine is an essential amino acid for nucleotide synthesis and an important energy resource for cellular division. There is contradictory evidence about its benefits as part of parenteral nutrition. More than 75% of bone marrow transplant patients (BMTP) have, during their evolution, digestive tract complications limiting enteral nutrition, for this reason, sometimes total parenteral nutrition (TPN) is required. Objective: Our aim was to analyze the relation between the use of glutamine in TPN of BMTP, and the evolution of clinical acute complications as mucositis, graft versus host disease (GVHD) and infections days of stay and days of TPN. Materials and Methods: observational retrospective study. All BMTP with total parenteral nutrition during the period 2007-2013 were included. We analyzed days of stay, days of nutrition, glutamine use and acute complications. Results were analyzed in SPSS 15.0. Results: 73 BMTP were divided in two comparable groups depending on glutamine use. The mean age was 36,96 ± 12,89 years. 47,9% of patients received glutamine in TPN. Patients who received glutamine had a mean stay of 31,49±7,41 days with 14,11±5,87 days of TPN compared with the non-glutamine group with 32,16±7,99 and 15,50±7,71 days respectively (p=0,71 y 0,39). Mucositis lasted 12,23±5,66 days in the glutamine group, and 15,50±7,71 days in the non-glutamine group (p=0,042). Severe grades of GVHD (II,III) was observed in 20,6% of the non glutamine group compared with the 13,7% of the other group (p=0,636). In patients with glutamine suplementation, mucositis last 12,23±5,66 days compared with 15,50±7,71 days in the non-glutamine group (p=0,042).13,7% of all patients suffered infections while receiving TPN with glutamine compared with 16,4% in patients who did not receive glutamine (p=0,700). Conclusion: In our group, a statistically significant reduction in the duration of mucositis was observed in patients who received parenteral glutamine

[Use of glutamine in total parenteral nutrition of bone marrow transplant patients]. / Uso de la glutamina en la nutricion parenteral total de pacientes sometidos a trasplante de médula ósea.

UNLABELLED: Glutamine is an essential amino acid for nucleotide synthesis and an important energy resource for cellular division. There is contradictory evidence about its benefits as part of parenteral nutrition. More than 75% of bone marrow transplant patients (BMTP) have, during their evolution, digestive tract complications limiting enteral nutrition, for this reason, sometimes total parenteral nutrition (TPN) is required. OBJECTIVE: Our aim was to analyze the relation between the use of glutamine in TPN of BMTP, and the evolution of clinical acute complications as mucositis, graft versus host disease (GVHD) and infections days of stay and days of TPN. MATERIALS AND METHODS: observational retrospective study. All BMTP with total parenteral nutrition during the period 2007-2013 were included. We analyzed days of stay, days of nutrition, glutamine use and acute complications. Results were analyzed in SPSS 15.0. RESULTS: 73 BMTP were divided in two comparable groups depending on glutamine use. The mean age was 36,96 ± 12,89 years. 47,9% of patients received glutamine in TPN. Patients who received glutamine had a mean stay of 31,49±7,41 days with 14,11±5,87 days of TPN compared with the non-glutamine group with 32,16±7,99 and 15,50±7,71 days respectively (p=0,71 y 0,39). Mucositis lasted 12,23±5,66 days in the glutamine group, and 15,50±7,71 days in the non-glutamine group (p=0,042). Severe grades of GVHD (II,III) was observed in 20,6% of the non glutamine group compared with the 13,7% of the other group (p=0,636). In patients with glutamine suplementation, mucositis last 12,23±5,66 days compared with 15,50±7,71 days in the non-glutamine group (p=0,042).13,7% of all patients suffered infections while receiving TPN with glutamine compared with 16,4% in patients who did not receive glutamine (p=0,700). CONCLUSION: In our group, a statistically significant reduction in the duration of mucositis was observed in patients who received parenteral glutamine.

La glutamina es un amioácido esencial para la síntesis de nucleótidos y una fuente de energía para la replicación celular, existe evidencia contradictoria respecto a los beneficios de su administración como parte de la nutrición parenteral en pacientes sometidos a trasplante de médula ósea (TMO). Más del 75% de los pacientes sometidos a trasplante de precursores hematopoyéticos, presentan durante su evolución complicaciones que comprometen el tracto digestivo, principalmente mucositis, limitando la ingesta oral, de allí la necesidad del uso de nutrición parenteral total (NPT) en estos casos. Objetivo: Analizar la relación entre uso de glutamina en la NPT de TMO y la evolución de complicaciones agudas como mucositis, EICH e infecciones, así como la estancia hospitalaria y los días de nutrición parenteral total. Material y métodos: Estudio observacional retrospectivo. Se incluyeron la totalidad de TMO con NPT entre 2007 y 2013 en nuestro hospital. Se analizaron días de hospitalización, días de soporte nutricional, uso de glutamina y complicaciones agudas. Los resultados se analizaron con el programa SPSS 15.0. Resultados: Se incluyeron 73 pacientes trasplantados, se dividieron en dos grupos según el aporte de glutamina siendo ambos grupos comparables entre sí. La edad media fue de 36,96±12,89 años. El 47,9% de los pacientes estudiados recibió suplemento de glutamina en la NPT. Los pacientes que recibieron glutamina tuvieron una estancia media de 31,49±7,41 días con 14,11±5,87 días de NPT en comparación a los que no recibieron glutamina con 32,16±7,99 y 15,50±7,71 días respectivamente (p=0,71 y 0,39). La duración de la mucositis en los pacientes que recibieron glutamina fue de 12,23±5,66 días comparado con 15,50±7,71 días en los que no recibieron glutamina (p=0,042).Se observaron grados severos de EICH (II, III) en un 20,6% de los pacientes sin glutamina en comparación al 13,7% en los que la recibieron (p=0,636). . Del total de los pacientes estudiados, el 13,7% sufrieron complicaciones infecciosas mientras recibían NPT con glutamina, comparado con 16,4% en pacientes que no recibieron (p=0,700).Conclusiones: En nuestra serie, se observó una reducción estadísticamente significativa en la duración de la mucositis en pacientes que recibieron NPT con glutamina.

Encefalopatía metabólica secundaria a intoxicación por vitamina D / Metabolic encephalopathy secondary to vitamin d intoxication

La asociación entre la deficiencia de vitamina D y un mayor riesgo de diversas enfermedades, entre ellas cardiovasculares y autoinmunes, ha aumentado en los últimos años el uso de suplementos para la normalización de los valores plasmáticos de esta vitamina. Desde entonces se ha descrito un mayor número de casos de intoxicación iatrogénica por vitamina D. Presentamos una enferma de 81 años con encefalopatía metabólica e insuficiencia renal secundarias a una intoxicación por vitamina D. Los suplementos orales con calcio y vitamina D se le prescribieron después de sufrir una fractura vertebral osteoporótica. La enferma mejoró clínica y analíticamente tras hidratación y diuréticos. Es importante destacar la hipercalcemia como causa de encefalopatía metabólica y considerar la intoxicación por vitamina D como etiología poco frecuente pero posible de hipercalcemia e insuficiencia renal reversibles (AU)

The association between vitamin D deficiency and increased risk of, among others, cardiovascular and autoimmune diseases has lead in the last years to an enhanced interest in the usage of supplements to achieve the normalization of plasmatic values at 25(OH) D. Apparently this search for normalization is resulting in an higher incidence on vitamin D intoxication. We present the case of an 81 years old woman with metabolic encephalopathy and renal failure secondary to iatrogenic vitamin D intoxication. Calcium and vitamin D oral supplements were prescribed after an osteoporotic vertebral fracture. The patient improved clinically as well as analytically after receiving treatment with diuretics and hydration. We emphasize the importance of discarding hypercalcemia as a cause of metabolic encephalopathy; moreover we highly recommend keeping vitamin D intoxication in mind as an uncommon although always possible etiology of reversible hypercalcemia and renal failure (AU)

Gastrostomía endóscopica percutánea en esclerosis lateral amiotrófica; experiencia en un hospital de tercer nivel / Percutaneous endoscopic gastrostomy in amyotrophic lateral sclerosis, experience in a district general hospital

Introducción: La Esclerosis Lateral Amiotrófica (ELA) es una enfermedad degenerativa neurológica con afectación de la vía piramidal, produciendo trastornos motores progresivos que evolucionan hasta la parálisis. Estos pacientes pueden asociar disfagia, precisando soporte nutricional a través de de sonda nasogástrica o Gastrostomía Endoscópica Percutánea (PEG). La PEG está asociada con aumento de la supervivencia, sin embargo la evidencia acerca del momento óptimo para su colocación es escasa. Objetivo: Analizar las características de los pacientes con ELA en el momento de colocación de la PEG y su evolución. Material y métodos: Estudio descriptivo retrospectivo. Se incluyeron pacientes con diagnóstico de ELA y PEG valorados durante los años 2005-2014 en nuestro hospital. Se analizaron parámetros nutricionales y respiratorios, y evolución de los pacientes. Los resultados se analizaron en el programa SPSS15. Resultados: 37 pacientes fueron incluidos (56,8% hombres, 43,2% mujeres) con una edad media al diagnóstico 60 años, y edad media de colocación de PEG de 63,1 años, el 48,6% debutó con afectación espinal y el 51,4%, con bulbar. El 43,2% de los pacientes recibieron suplementos previa colocación de PEG durante un promedio de 11,3 meses. La capacidad vital forzada (CVF) media al diagnóstico fue del 65,45±13,67%, evolucionando desfavorablemente hasta un 39,47±14,69% en el momento de colocación de la PEG. El 86,5% de los pacientes precisaron soporte respiratorio con ventilación mecánica no invasiva (VMNI). El 86,5% presentaron disfagia, el 64,9% pérdida de peso > 5-10% de su peso habitual, el 8,1% IMC bajo, el 27% parámetros bioquímicos de desnutrición y el 73% empeoramiento de función respiratoria, por tanto, el 100% cumplían criterios de colocación de PEG según nuestro protocolo. La duración de la nutrición enteral fue de 10,1 meses con una mortalidad del 50% en los primeros 6 meses de la colocación de la PEG. Conclusiones: Evidenciamos una demora de 3 años entre el diagnóstico y la colocación de la PEG, con una supervivencia del 50% a los 6 meses de la realización de la misma. Más estudios son necesarios para determinar si una colocación más precoz podría aumentar la supervivencia (AU)

Background: Amyotrophic Lateral Sclerosis (ALS) is a degenerative disorder that affects the pyramidal tract, producing progressive motor dysfunctions leading to paralysis. These patients can present with dysphagia, requiring nutritional support with a nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG). PEG is associated with increased survival rates. However, the timing of PEG placement remains a significant issue for clinicians. Objective: To analyse the characteristics of ALS patients at the moment of PEG placement and their progression. Methods and materials: Descriptive retrospective study including patients diagnosed with ALS and PEG who were assessed during the 2005-2014 period in our hospital. Nutritional parameters and respiratory function were assessed for all patients, as well as their progression. The data was analysed using SPSS15. Results: 37 patients were included (56.8% men, 43.2% women) with an average age of 60 at diagnosis, and an average age of 63.1 at PEG placement. 48.6% started with spinal affection and 51.4%, with bulbar affection. 43.2% of the patients received oral nutritional supplements prior to PEG placement for a mean period of 11.3 months. The mean forced vital capacity at diagnosis was 65.45±13.67%, with a negative progression up to 39.47±14.69% at the moment of PEG placement. 86.5% of patients required non-invasive positive-pressure ventilation. 86.5% presented with dysphagia, 64.9% with weight loss > 5-10% from their usual weight, 8.1% with low Body Mass Index, 27% with malnutrition and 73% with aworsened breathing function; therefore, 100% met the criteria for PEG placement according to our protocol. The period on enteral feeding was extended for 10.1 months with a mortality of 50% during the first 6 months from PEG placement. Conclusions: There is evidence of a 3-year delay between diagnosis and PEG placement, with a survival rate of 50% at 6 months from PEG insertion. Further studies are required to establish whether an earlier placement might increase survival rates (AU)

[Percutaneous endoscopic gastrostomy in a myotrophic lateral sclerosis. Experience in a district general hospital]. / Gastrostomía endóscopica percutánea en esclerosis lateral amiotrófica; experiencia en un hospital de tercer nivel.

BACKGROUND: Amyotrophic Lateral Sclerosis (ALS) is a degenerative disorder that affects the pyramidal tract, producing progressive motor dysfunctions leading to paralysis. These patients can present with dysphagia, requiring nutritional support with a nasogastric tube or Percutaneous Endoscopic Gastrostomy (PEG). PEG is associated with increased survival rates. However, the timing of PEG placement remains a significant issue for clinicians. OBJECTIVE: To analyse the characteristics of ALS patients at the moment of PEG placement and their progression. METHODS AND MATERIALS: Descriptive retrospective study including patients diagnosed with ALS and PEG who were assessed during the 2005-2014 period in our hospital. Nutritional parameters and respiratory function were assessed for all patients, as well as their progression. The data was analysed using SPSS15. RESULTS: 37 patients were included (56.8% men, 43.2% women) with an average age of 60 at diagnosis, and an average age of 63.1 at PEG placement. 48.6% started with spinal affection and 51.4%, with bulbar affection. 43.2% of the patients received oral nutritional supplements prior to PEG placement for a mean period of 11.3 months. The mean forced vital capacity at diagnosis was 65.45±13.67%, with a negative progression up to 39.47±14.69% at the moment of PEG placement. 86.5% of patients required non-invasive positive-pressure ventilation. 86.5% presented with dysphagia, 64.9% with weight loss > 5-10% from their usual weight, 8.1% with low Body Mass Index, 27% with malnutrition and 73% with aworsened breathing function; therefore, 100% met the criteria for PEG placement according to our protocol. The period on enteral feeding was extended for 10.1 months with a mortality of 50% during the first 6 months from PEG placement. CONCLUSIONS: There is evidence of a 3-year delay between diagnosis and PEG placement, with a survival rate of 50% at 6 months from PEG insertion. Further studies are required to establish whether an earlier placement might increase survival rates.

Introducción: La Esclerosis Lateral Amiotrófica (ELA) es una enfermedad degenerativa neurológica con afectación de la vía piramidal, produciendo trastornos motores progresivos que evolucionan hasta la parálisis. Estos pacientes pueden asociar disfagia, precisando soporte nutricional a través de de sonda nasogástrica o Gastrostomía Endoscópica Percutánea (PEG). La PEG está asociada con aumento de la supervivencia, sin embargo la evidencia acerca del momento óptimo para su colocación es escasa. Objetivo: Analizar las características de los pacientes con ELA en el momento de colocación de la PEG y su evolución. Material y métodos: Estudio descriptivo retrospectivo. Se incluyeron pacientes con diagnóstico de ELA y PEG valorados durante los años 2005-2014 en nuestro hospital. Se analizaron parámetros nutricionales y respiratorios, y evolución de los pacientes. Los resultados se analizaron en el programa SPSS15. Resultados: 37 pacientes fueron incluidos (56,8% hombres, 43,2% mujeres) con una edad media al diagnóstico 60 años, y edad media de colocación de PEG de 63,1 años, el 48,6% debutó con afectación espinal y el 51,4%, con bulbar. El 43,2% de los pacientes recibieron suplementos previa colocación de PEG durante un promedio de 11,3 meses. La capacidad vital forzada (CVF) media al diagnóstico fue del 65,45±13,67%, evolucionando desfavorablemente hasta un 39,47±14,69% en el momento de colocación de la PEG. El 86,5% de los pacientes precisaron soporte respiratorio con ventilación mecánica no invasiva (VMNI). El 86,5% presentaron disfagia, el 64,9% pérdida de peso > 5-10% de su peso habitual, el 8,1% IMC bajo, el 27% parámetros bioquímicos de desnutrición y el 73% empeoramiento de función respiratoria, por tanto, el 100% cumplían criterios de colocación de PEG según nuestro protocolo. La duración de la nutrición enteral fue de 10,1 meses con una mortalidad del 50% en los primeros 6 meses de la colocación de la PEG. Conclusiones: Evidenciamos una demora de 3 años entre el diagnóstico y la colocación de la PEG, con una supervivencia del 50% a los 6 meses de la realización de la misma. Más estudios son necesarios para determinar si una colocación más precoz podría aumentar la supervivencia.

[Screening for Cushing's syndrome in obese patients; is it really necessary?]. / Despistaje rutinario de síndrome de Cushing en pacientes con obesidad mórbida: ¿es realmente necesario?

to be more frequent among patients with metabolic syndrome. Previous studies have suggested to perform a routine screening for CS in obese patients; however, more recent reports only recommend a case-finding approach in patients with uncontrolled diabetes and hypertension, despite appropriate treatment. Objective: The aim of this study was to evaluate the prevalence of unsuspected CS in morbidly obese patients in an outpatient's clinic. Patients and methods: Retrospective case-note study. We reviewed the medical records of morbidly obese patients referred to our clinic prior to bariatric surgery between january 2001 and december 2011. All patients had a complete medical history including physical examination, and 399 underwent screening for CS as part of our pre-surgical protocol. As screening for autonomous cortisol secretion, we performed an overnight 1 mg Dexamethasone Suppression Test (DST). Serum cortisol < 1.8 µg/dl was the cut-off point for normal suppression. Results: 399 patients (308 female; mean age 41.9 ± 10.5 years; mean BMI 51.5 ± 8.4 kg/m2). In the retrospective analysis, prediabetes and diabetes mellitus were observed in 10.3% and 27.8% respectively. In 21 of 399 patients, screening was considered to be abnormal. Eight of these 21 patients had subsequent normal 24h Urinary Free Cortisol (UFC) levels (150 µg/24h). In 13 of 20 patients, we repeated an overnight 1mg DST, on suspicion of failing to take the dexamethasone correctly. Three patients failed to suppress their cortisol levels, two of them were on carbamazepine, which was considered to be a false positive result. The other patient with abnormal UFC levels was diagnosed with CS (0.26%), whose cause was a pituitary microadenoma. Conclusion: A low proportion of patients with morbid obesity were found to have CS. Our findings suggest that morbidly obese patients should not be routinely screened for CS.

Introducción: El síndrome de Cushing (SC) es más frecuente en pacientes con síndrome metabólico. Estudios previos han sugerido que es necesario realizar un despistaje de SC en pacientes obesos; sin embargo, estudios más recientes sólo recomiendan el despistaje en pacientes con hipertensión o diabetes mal controlados, a pesar de tratamiento. Objetivo: Evaluar la prevalencia de SC oculto en pacientes con obesidad mórbida. Pacientes y métodos: Estudio observacional retrospectivo en el que se incluyeron 399 pacientes que iban a someterse a cirugía bariátrica. A todos los pacientes se les realizó una historia clínica completa, incluyendo exploración física y test de Nugent, como parte del protocolo precirugía. Resultados: 399 pacientes (308 mujeres, edad media 41,9 ± 10,5 años; IMC medio 51,5 ± 8,4 kg/m2). El 10,3% de los pacientes presentaban prediabetes y el 27,8% diabetes. En 21 de los 399 pacientes, el despistaje fue anormal. En 8 pacientes, medimos cortisol libre en orina de 24 horas (CLU), siendo en todos normal al menos en dos ocasiones (CLU < 150 mcg/24 h), lo que descartaba SC. En 13 pacientes, repetimos el test de Nugent; sólo en 3, el test resultó patológico. Dos de los pacientes estaban en tratamiento con carbamacepina, lo que se consideró un falso positivo. El otro paciente se diagnosticó de Enfermedad de Cushing. Conclusión: La prevalencia de SC fue muy baja en pacientes con obesidad mórbida. Nuestros datos sugieren que no se debería realizarse un despistaje de SC de forma rutinaria.

Despistaje rutinario de Síndrome de Cushing en pacientes con obesidad mórbida; ¿es realmente necesario? / Screeening for cushing’s syndrome in obese patients: is it really necessary?

Introducción: El síndrome de Cushing (SC) es más frecuente en pacientes con síndrome metabólico. Estudios previos han sugerido que es necesario realizar un despistaje de SC en pacientes obesos; sin embargo, estudios más recientes sólo recomiendan el despistaje en pacientes con hipertensión o diabetes mal controlados, a pesar de tratamiento. Objetivo: Evaluar la prevalencia de SC oculto en pacientes con obesidad mórbida. Pacientes y métodos: Estudio observacional retrospectivo en el que se incluyeron 399 pacientes que iban a someterse a cirugía bariátrica. A todos los pacientes se les realizó una historia clínica completa, incluyendo exploración física y test de Nugent, como parte del protocolo precirugía. Resultados: 399 pacientes (308 mujeres, edad media 41,9 ± 10,5 años; IMC medio 51,5 ± 8,4 kg/m2 ). El 10,3% de los pacientes presentaban prediabetes y el 27,8% diabetes. En 21 de los 399 pacientes, el despistaje fue anormal. En 8 pacientes, medimos cortisol libre en orina de 24 horas (CLU), siendo en todos normal al menos en dos ocasiones (CLU < 150 mcg/24 h), lo que descartaba SC. En 13 pacientes, repetimos el test de Nugent; sólo en 3, el test resultó patológico. Dos de los pacientes estaban en tratamiento con carbamacepina, lo que se consideró un falso positivo. El otro paciente se diagnosticó de Enfermedad de Cushing. Conclusión: La prevalencia de SC fue muy baja en pacientes con obesidad mórbida. Nuestros datos sugieren que no se debería realizarse un despistaje de SC de forma rutinaria (AU)

Background: Cushing’s syndrome (CS) is considered to be more frequent among patients with metabolic syndrome. Previous studies have suggested to perform a routine screening for CS in obese patients; however, more recent reports only recommend a case-finding approach in patients with uncontrolled diabetes and hypertension, despite appropriate treatment. Objective: The aim of this study was to evaluate the prevalence of unsuspected CS in morbidly obese patients in an outpatient’s clinic. Patients and methods: Retrospective case-note study. We reviewed the medical records of morbidly obese patients referred to our clinic prior to bariatric surgery between january 2001 and december 2011. All patients had a complete medical history including physical examination, and 399 underwent screening for CS as part of our pre-surgical protocol. As screening for autonomous cortisol secretion, we performed an overnight 1 mg Dexamethasone Suppression Test (DST). Serum cortisol < 1.8 µg/dl was the cut-off point for normal suppression. Results: 399 patients (308 female; mean age 41.9 ± 10.5 years; mean BMI 51.5 ± 8.4 kg/m2). In the retrospective analysis, prediabetes and diabetes mellitus were observed in 10.3% and 27.8% respectively. In 21 of 399 patients, screening was considered to be abnormal. Eight of these 21 patients had subsequent normal 24h Urinary Free Cortisol (UFC) levels (150 µg/24h). In 13 of 20 patients, we repeated an overnight 1mg DST, on suspicion of failing to take the dexamethasone correctly. Three patients failed to suppress their cortisol levels, two of them were on carbamazepine, which was considered to be a false positive result. The other patient with abnormal UFC levels was diagnosed with CS (0.26%), whose cause was a pituitary microadenoma. Conclusion: A low proportion of patients with morbid obesity were found to have CS. Our findings suggest that morbidly obese patients should not be routinely screened for CS (AU)

[Metabolic encephalopathy secondary to vitamin D intoxication]. / Encefalopatía metabólica secundaria a intoxicación por vitamina D.

The association between vitamin D deficiency and increased risk of, among others, cardiovascular and autoimmune diseases has lead in the last years to an enhanced interest in the usage of supplements to achieve the normalization of plasmatic values at 25(OH) D. Apparently this search for normalization is resulting in an higher incidence on vitamin D intoxication. We present the case of an 81 years old woman with metabolic encephalopathy and renal failure secondary to iatrogenic vitamin D intoxication. Calcium and vitamin D oral supplements were prescribed after an osteoporotic vertebral fracture. The patient improved clinically as well as analytically after receiving treatment with diuretics and hydration. We emphasize the importance of discarding hypercalcemia as a cause of metabolic encephalopathy; moreover we highly recommend keeping vitamin D intoxication in mind as an uncommon although always possible etiology of reversible hypercalcemia and renal failure.

La asociación entre la deficiencia de vitamina D y un mayor riesgo de diversas enfermedades, entre ellas cardiovasculares y autoinmunes, ha aumentado en los últimos años el uso de suplementos para la normalización de los valores plasmáticos de esta vitamina. Desde entonces se ha descrito un mayor número de casos de intoxicación iatrogénica por vitamina D. Presentamos una enferma de 81 años con encefalopatía metabólica e insuficiencia renal secundarias a una intoxicación por vitamina D. Los suplementos orales con calcio y vitamina D se le prescribieron después de sufrir una fractura vertebral osteoporótica. La enferma mejoró clínica y analíticamente tras hidratación y diuréticos. Es importante destacar la hipercalcemia como causa de encefalopatía metabólica y considerar la intoxicación por vitamina D como etiología poco frecuente pero posible de hipercalcemia e insuficiencia renal reversibles.

[Bariatric surgery in inflammatory bowel disease; case report and review of the literature]. / Cirugía bariátrica en enfermedad inflamatoria intestinal; presentación de un caso clínico y revisión de la literatura.

Inflammatory bowel disease (IBD) is rarely associated with obesity, as malabsorption is a common feature of these diseases (1). However, some patients may experience morbid obesity and associated complications refractory to dietary treatment and benefit from bariatric surgery. It has even been postulated that surgery may result in improvement of IBD by reducing inflammatory markers (2). However, patients may experience a higher incidence of complications following surgery in the context of immunosuppressive therapy and prior malabsorption. Therefore, if surgery is performed, careful patient selection and individualization of technique are essential. We present a patient diagnosed with ulcerative colitis who presented severe protein malnutrition after bariatric surgery type bilio-pancreatic diversion and review the available literature.

La Enfermedad Inflamatoria Intestinal (EII) raramente se asocia a obesidad, ya que la malabsorción es una característica frecuente de este grupo de patologías (1). Sin embargo, algunos pacientes pueden padecer obesidad mórbida asociada a complicaciones y refractaria a tratamiento dietético y beneficiarse de la cirugía bariátrica. Incluso se ha postulado que podría producirse una mejoría de la EII al disminuir los marcadores inflamatorios tras la cirugía (2). No obstante, los pacientes pueden experimentar mayor incidencia de complicaciones tras la cirugía en el contexto de terapias inmunosupresoras y agravamiento de la malabsorción previa. Por ello, si se realiza la cirugía, la cuidadosa selección de los pacientes y la individualización de la técnica a realizar son imprescindibles. Presentamos una paciente diagnosticada de Colitis Ulcerosa que presenta desnutrición proteica severa tras cirugía bariátrica tipo derivación bilio-pancreática y realizamos una revisión de la literatura disponible.

Cirugía bariátrica en enfermedad inflamatoria intestinal; presentación de un caso clínico y revisión de la literatura / Bariatric surgery in inflammatory bowel disease; case report and review of the literature

La Enfermedad Inflamatoria Intestinal (EII) raramente se asocia a obesidad, ya que la malabsorción es una característica frecuente de este grupo de patologías (1). Sin embargo, algunos pacientes pueden padecer obesidad mórbida asociada a complicaciones y refractaria a tratamiento dietético y beneficiarse de la cirugía bariátrica. Incluso se ha postulado que podría producirse una mejoría de la EII al disminuir los marcadores inflamatorios tras la cirugía (2). No obstante, los pacientes pueden experimentar mayor incidencia de complicaciones tras la cirugía en el contexto de terapias inmunosupresoras y agravamiento de la malabsorción previa. Por ello, si se realiza la cirugía, la cuidadosa selección de los pacientes y la individualización de la técnica a realizar son imprescindibles. Presentamos una paciente diagnosticada de Colitis Ulcerosa que presenta desnutrición proteica severa tras cirugía bariátrica tipo derivación bilio-pancreática y realizamos una revisión de la literatura disponible (AU)

Inflammatory bowel disease (IBD) is rarely associated with obesity, as malabsorption is a common feature of these diseases (1). However, some patients may experience morbid obesity and associated complications refractory to dietary treatment and benefit from bariatric surgery. It has even been postulated that surgery may result in improvement of IBD by reducing inflammatory markers (2). However, patients may experience a higher incidence of complications following surgery in the context of immunosuppressive therapy and prior malabsorption. Therefore, if surgery is performed, careful patient selection and individualization of technique are essential. We present a patient diagnosed with ulcerative colitis who presented severe protein malnutrition after bariatric surgery type bilio-pancreatic diversion and review the available literature (AU)

Eficacia y seguridad de la insulina aspartato bifásica 30/70 en el tratamiento de pacientes con diabetes mellitus tipo 2 / Efficacy and safety of biphasic insulin aspart 30/70 in the treatment of patients with type 2 diabetes mellitus

Objetivo: Evaluar la seguridad y la eficacia de la insulina aspartato bifásica 30/70 en pacientes con diabetes mellitus tipo 2 (DM2). Material y métodos: Estudio observacional, multicéntrico y prospectivo. Participaron en el estudio 3.054 pacientes con DM2 procedentes de atención primaria y especializada en tratamiento con insulina aspartato bifásica 30/70 (iniciado en los 15 días previos a la inclusión). De todos ellos se disponía de la siguiente información previa al inicio del tratamiento con dicha insulina: glucohemoglobina (HbA1c), glucemia en ayunas (GA), perfil de glucosa 4 puntos (antes y 90 min después de desayuno y cena) y número de hipoglucemias/semana; 2.887 completaron el estudio (26 ± 1 semana). Las variables analizadas fueron: frecuencia de acontecimientos adversos, hipoglucemias/semana, HbA1c, GA y perfil glucémico de 4 puntos. Resultados: El 10,7% de los pacientes presentaron algún acontecimiento adverso (el 2,3% relacionados con el tratamiento y el 1,4%, graves). Hubo un descenso significativo (final del estudio frente a basal, p < 0,0001 en todas las comparaciones) de las cifras de HbA1c (el 7,3 y el 8,9%, respectivamente), media de hipoglucemias/semana menores (0,3 y 0,5) y mayores (0,02 y 0,07), GA (145 y 207 mg/dl) y glucemia posprandial (162 y 225 mg/dl). La mejoría en el control metabólico se consiguió tanto en pacientes tratados previamente con antidiabéticos orales como con insulina. El número de hipoglucemias disminuyó en los tratados previamente con insulina. Conclusiones: El tratamiento con insulina aspartato bifásica 30/70 en pacientes con DM2 mejora el control glucémico con independencia del tratamiento previo, con una tasa baja de acontecimientos adversos y un número menor de hipoglucemias que en los tratados previamente con insulina (AU)

Objective: To assess the safety and efficacy of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus (DM2). Material and methods: We performed an observational, multicenter, prospective study in 3,054 DM2 patients from primary care and specialized settings, treated with biphasic insulin aspart 30/70 (started within 15 days prior to inclusion). In all patients, the following information was available before starting insulin treatment: HbA1c levels, fasting plasma glucose (FPG), 4-point glucose profile (before and 90 minutes after breakfast and dinner) and number of hypoglycemic episodes/week. A total of 2,887 patients completed the study (26 ± 1 week). The variables evaluated were rate of adverse events (AE), number of hypoglycemic episodes/week, HbA1c, FPG and 4-point glucose profile. Results: At least one AE occurred in 10.7% of the patients (2.3% related to the study drug and 1.4% severe). There was a significant decrease (end of study vs baseline; p < 0.0001 for all the comparisons) in HbA1c (7.3% and 8.9%, respectively), the mean number of minor (0.3/0.5) and major (0.02/0.07) hypoglycemic episodes/week, FPG (145/207 mg/dl) and postprandial glycemia (162/225 mg/dl). The improvement in metabolic control was achieved both in patients previously treated with oral antidiabetic drugs and in those treated with insulin. The number of hypoglycemic episodes decreased in patients previously treated with insulin. Conclusions: Treatment with biphasic insulin aspart 30/70 in patients with DM2 improves glycemic control, irrespective of previous treatment, with a low rate of AE and fewer hypoglycemic episodes in patients previously treated with insulin (AU)

Efficacy and safety of biphasic insulin aspart 30/70 in the treatment of patients with type 2 diabetes mellitus.

OBJECTIVE: To assess the safety and efficacy of biphasic insulin aspart 30/70 in patients with type 2 diabetes mellitus (DM2). MATERIAL AND METHODS: We performed an observational, multicenter, prospective study in 3,054 DM2 patients from primary care and specialized settings, treated with biphasic insulin aspart 30/70 (started within 15 days prior to inclusion). In all patients,the following information was available before starting insulin treatment: HbA(1c) levels, fasting plasma glucose (FPG), 4-point glucose profile (before and 90 minutes after breakfast and dinner) and number of hypoglycemic episodes/week. A total of 2,887 patients completed the study (26 ± 1 week). The variables evaluated were rate of adverse events (AE), number of hypoglycemic episodes/week, HbA(1c), FPG and 4-point glucose profile. RESULTS: At least one AE occurred in 10.7% of the patients (2.3% related to the study drug and 1.4% severe). There was a significant decrease (end of study vs baseline; p < 0.0001 for all the comparisons) in HbA(1c) (7.3% and 8.9%, respectively), the mean number of minor (0.3/0.5) and major (0.02/0.07) hypoglycemic episodes/week, FPG (145/207 mg/dl) and postprandial glycemia (162/225 mg/dl). The improvement in metabolic control was achieved both in patients previously treated with oral antidiabetic drugs and in those treated with insulin. The number of hypoglycemic episodes decreased in patients previously treated with insulin. CONCLUSIONS: Treatment with biphasic insulin aspart 30/70 in patients with DM2 improves glycemic control, irrespective of previous treatment, with a low rate of AE and fewer hypoglycemic episodes in patients previously treated with insulin.